Mabion obtains positive FDA-EMA report

Publish date: 2012-11-28

Mabion SA — Polish biotechnological company, which develops and introduces the latest generation of drugs based on humanized monoclonal antibodies to the market, has received a document informing about termination of Scientific Advice joint procedure conducted by the European Medicines Agency and the U.S. Food and Drugs Administration concerning MabionCD20 drug. The company has presented the results of subsequent qualitative researches and has achieved positive opinion on the crucial matters and the acceptance of adopted solutions. The regulatory risk of MabionCD20 addmition to trading has thereby been diminished and the possibility of regulatory and marketing plans preparations initiation on the US market has been confirmed.

As part of the conducted procedure the company has also achieved the confirmation of adopted and agreed solutions as well as clinical trials documents which will allow the clinical bioequivalence of MabionCD20 and referential drug MabThera to be confirmed after the programme termination. In December of 2011 Mabion conducted — as the only Polish company so far — scientific advice procedure in the European Medicines Agency, which topic was among others the range and methodics of clinical trials of MabionCD20.

'The opinion issued as a part of the joint procedure of EMA and FDA concerning MabionCD20 drug is an extremely important step in the long-term sales and distribution planning of our medicament. USA market is the next, huge potential consumer, to which we would like to get. Recently conducted development and implementation of drug activities will now proceed in accordance to the EMA guidelines, which will be a crucial condition for MabionCD20 registration in the EU Member States. Now we know, that our clinical trial are beeing conducted in accordance to the FDA point of view in the field of biosimilarities. If we add to this 5 letters of intent signed in the unregulated markets, it can be surely seen how complex and meticulous weare preparing ourselves to introduce the MabionCD20 to the world market' — says Maciej Wieczorek, president of the board of Mabion SA.

MabionCD20 development is curently at basic and the most important phase. The company is at the stage of permissions acquiring — from Ministries of Health and bioethical commisions from 8 countries, in which Mabion plans to conduct the trials. Until now the company has submitted motions for proper permissions in 5 countries: Lithuania, Ukraine, Serbia, Russia and Georgia. Moreover, the company has already obtained an approval for clinical trials from Lithuanian bioethical commision. Human trials are the last phase of the procedure preceding drug registration. Termination of clinical trials will allow to prepare the qualitative and research documentation, which is a substential part of the drug registration dossier. It will be submitted to EMA in the process of Mabion20 approval for authorisation.

'The main aim of Mabion is to introduce the biosimilar drugs to the global markets regarding the patent protection expiring dates. The global sales of referential MabThera are estimated at 4,6 billion EURO annualy. This is a great perspective for Mabion'— Maciej Wieczorek adds.

Mabion intends to conduct the MabionCD20 registration process in the whole EU by itself. Biosimilar drugs registration system in Member States is relatively well regulated. The company will sell drugs by its own in the territory of Poland and neighbour states, but will sign distributional contracts with local operators in other EU countries. In case of regions with weaker registration system — on the unregulated markets — Mabion plans to cede both sales and the whole registration procedure to leading local pharmaceutical companies. Drugs will be produced in Mabion's manifacturing plants in Poland and the firm will have a share in the incomes from sales of drugs by foreign distributors.

Adam Klamra

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